GingivitisPhase 2NCT02809313
Clinical and Microbiological Effects of Lactobacillus Rhamnosus in Treatment of Gingivitis
A Phase 2 study testing Treatment Gingivitis with Probiotic and Treatment Gingivitis conventional in people with Gingivitis, run by Jorge Gamonal at 1 site in Chile.
Trial summary
The aim of this randomized placebo- controlled clinical trial is to evaluate the effects of Lactobacillus rhamnosus SP1- containing probiotic sachet as an adjunct to scaling and root planning (SRP). Read more about this study
- Who is it for?
- Ages 17 to 28 years
- Conditions the study is for
- Gingivitis
- What is being tested?
- Treatment Gingivitis with Probiotic and Treatment Gingivitis conventional
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteChile
- Study dates
- Mar 2016to Nov 2016
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 to 28 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Diagnosis of Gingivitis
- Gingival index > 1.5 (> 10 % of the sites examined)
- Index increased bleeding on probing 10% of the sites surveyed
- Probing Depth < 3 mm
- Systemically healthy (except for the presence of gingivitis)
- Patients who have not received periodontal treatment and before no intake of medicines such as antibiotics and / or anti-inflammatory in the last 3 months prior to the start of the study
Who cannot join
- Patients who develop systemic disease during the study.
- Patients who have to ingest antibiotics and / or antiinflammatories during the study.
- If you are a woman becomes pregnant during the study.
Trial locations and contacts
1 site in 1 country.
Chile1 site, 1 recruiting
- Recruiting
Faculty of Dentistry of University of Chile
Santiago, Santiago Metropolitan
Jorge A Gamonal, Profesor, +56229781839
Joel E Bravo Bown, Professor
About this study
Official title: Clinical and Microbiological Effects of Lactobacillus Rhamnosus in Treatment of Gingivitis: a Randomized Placebo-controlled Trials With 3-month Follow-up
The aim of this randomized placebo- controlled clinical trial is to evaluate the effects of Lactobacillus rhamnosus SP1- containing probiotic sachet as an adjunct to scaling and root planning (SRP). Material and methods: Thirty six gingivitis patients will be recruited and monitored clinically and microbiologically at baseline and 3-6 months after therapy. All patients will receive scaling and periodontal treatment and randomly will be assigned over an experimental (SRP + probiotic, n=18) or control (SRP + placebo, n=18) group. The sachet will be used once per day during 3 months.
Read the detailed description
Gingivitis is the most prevalent worldwide periodontal disease, is characterized by inflammation of the tissues surrounding the tooth without causing periodontal attachment loss. Preventive and / or therapeutic measures to facilitate or improve their control are therefore very important, much more if you consider that gingivitis and periodontitis are considered part of an ongoing inflammatory process. Treatment of gingivitis, like that of all periodontal diseases has been based on the implementation of control measures personal and professional plaque. Notwithstanding the foregoing, it has been reported that although mechanical therapy achieved significantly decrease the periodontopathogens, this may be only temporary since bacteria can recolonize the treated niches in the oral cavity. In this context, it has emerged as a new treatment strategy complementary use of probiotics such as Lactobacillus rhamnosus, which possess anti-bacterial and anti-inflammatory properties. Generally speaking, probiotics would promote health by competitive exclusion of some or positive pathogenic bacteria. Objective: To evaluate the effect of the administration of Lactobacillus rhamnosus as an adjunct to conventional periodontal therapy in adolescent and young adult patients with gingivitis. Methodology: A randomized double-blind clinical trial to evaluate the effect of sachet probiotic Lactobacillus rhamnosus as an adjunct to conventional periodontal treatment of patients with gingivitis will be performed. Expected Results: Statistically significant decrease in levels of periodontopathogens (P. gingivalis, A. actinomycetemcomitans, T. forsythia and A. viscosus) in the experimental group compared with the control. Association between clinical and microbiological parameters.
- Conditions
- Gingivitis
- Being tested
- Treatment Gingivitis with Probiotic, Treatment Gingivitis conventional
- Keywords
- gingivitis, probiotic, non- surgical treatment
- Medical subject headings
- Gingivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment Gingivitis with ProbioticDietary supplement
gingivitis treatment (scaling and coronary polish) and one sachet containing Lactobacillus rhamnosus SP1 per day during 3 months
Treatment Gingivitis conventionalOther
gingivitis treatment (scaling and coronary polish) and one sachet containing Placebo (talc powder) per day during 3 months
| Study group | Role | What they receive |
|---|---|---|
| Treatment Gingivitis with Probiotic | Experimental | Gingivitis group of patient treated with conventional therapy (scaling, coronary polish and oral hygiene instruction) and adjunct probiotic containing one sachet Lactobacillus rhamnosus per day during 3 month Receives: Dietary Supplement: Treatment Gingivitis with Probiotic |
| Treatment Gingivitis conventional | Placebo comparator | Gingivitis group of patient treated with conventional therapy (scaling, coronary polish and oral hygiene instruction) and adjunct placebo containing one sachet placebo (talc power) per day during 3 month Receives: Other: Treatment Gingivitis conventional |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences between groups for bleeding on probing changes
Measured: baseline, 3 month, 6 month
Secondary outcomes (3)
Differences between groups for gingival index
Measured: baseline, 3 month, 6 month
Differences between groups for detection of periodontal pathogens
- gingivalis, A. actinomicetemcomitans, T. forsythia and A. viscosus
Measured: baseline, 3 month, 6 month
Differences between groups for levels of periodontal pathogens changes
- gingivalis, A. actinomicetemcomitans, T. forsythia and A. viscosus
Measured: baseline, 3 month, 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2016 (estimated)
- Study startMar 2016
- Primary completionOct 2016 (estimated)
- Study completionNov 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GingivitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jorge Gamonal
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jorge Gamonal, University of Chile
- Investigators
- Jorge Gamonal Aravena, Proffesor, Principal investigator, Faculty of Dentistry of University of Chile
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02809313
- Sponsor's protocol ID
- 1130570
- Status last verified
- Jun 2016
- First submitted
- 13 Jun 2016
- Last updated
- 26 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Microbiological Effects of Lactobacillus Rhamnosus in Treatment of Gingivitis: a Randomized Placebo-controlled Trials With 3-month Follow-up
- ClinicalTrials.gov ID
- NCT02809313
- Acronym / sponsor ID
- 1130570
- Conditions
- Gingivitis
- Keywords
- gingivitis, probiotic, non- surgical treatment
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Jorge GamonalUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- Oct 2016 (estimated)
- Study completion
- Nov 2016 (estimated)
- First posted
- 22 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this randomized placebo- controlled clinical trial is to evaluate the effects of Lactobacillus rhamnosus SP1- containing probiotic sachet as an adjunct to scaling and root planning (SRP). Material and methods: Thirty six gingivitis patients will be recruited and monitored clinically and microbiologically at baseline and 3-6 months after therapy. All patients will receive scaling and periodontal treatment and randomly will be assigned over an experimental (SRP + probiotic, n=18) or control (SRP + placebo, n=18) group. The sachet will be used once per day during 3 months.
Detailed description
Gingivitis is the most prevalent worldwide periodontal disease, is characterized by inflammation of the tissues surrounding the tooth without causing periodontal attachment loss. Preventive and / or therapeutic measures to facilitate or improve their control are therefore very important, much more if you consider that gingivitis and periodontitis are considered part of an ongoing inflammatory process. Treatment of gingivitis, like that of all periodontal diseases has been based on the implementation of control measures personal and professional plaque. Notwithstanding the foregoing, it has been reported that although mechanical therapy achieved significantly decrease the periodontopathogens, this may be only temporary since bacteria can recolonize the treated niches in the oral cavity. In this context, it has emerged as a new treatment strategy complementary use of probiotics such as Lactobacillus rhamnosus, which possess anti-bacterial and anti-inflammatory properties. Generally speaking, probiotics would promote health by competitive exclusion of some or positive pathogenic bacteria. Objective: To evaluate the effect of the administration of Lactobacillus rhamnosus as an adjunct to conventional periodontal therapy in adolescent and young adult patients with gingivitis. Methodology: A randomized double-blind clinical trial to evaluate the effect of sachet probiotic Lactobacillus rhamnosus as an adjunct to conventional periodontal treatment of patients with gingivitis will be performed. Expected Results: Statistically significant decrease in levels of periodontopathogens (P. gingivalis, A. actinomycetemcomitans, T. forsythia and A. viscosus) in the experimental group compared with the control. Association between clinical and microbiological parameters.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Gingivitis with Probiotic | Experimental | Dietary Supplement: Treatment Gingivitis with ProbioticGingivitis group of patient treated with conventional therapy (scaling, coronary polish and oral hygiene instruction) and adjunct probiotic containing one sachet Lactobacillus rhamnosus per day during 3 month |
| Treatment Gingivitis conventional | Placebo comparator | Other: Treatment Gingivitis conventionalGingivitis group of patient treated with conventional therapy (scaling, coronary polish and oral hygiene instruction) and adjunct placebo containing one sachet placebo (talc power) per day during 3 month |
Who may qualify
- Ages
- 17 to 28 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Diagnosis of Gingivitis
- Gingival index > 1.5 (> 10 % of the sites examined)
- Index increased bleeding on probing 10% of the sites surveyed
- Probing Depth < 3 mm
- Systemically healthy (except for the presence of gingivitis)
Key exclusion criteria (3 listed)
- Patients who develop systemic disease during the study.
- Patients who have to ingest antibiotics and / or antiinflammatories during the study.
- If you are a woman becomes pregnant during the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Treatment Gingivitis with Probioticgingivitis treatment (scaling and coronary polish) and one sachet containing Lactobacillus rhamnosus SP1 per day during 3 months | Dietary supplement | Treatment Gingivitis with Probiotic |
| Treatment Gingivitis conventionalgingivitis treatment (scaling and coronary polish) and one sachet containing Placebo (talc powder) per day during 3 months | Other | Treatment Gingivitis conventional |
Primary outcome
Differences between groups for bleeding on probing changes
Time frame: baseline, 3 month, 6 month
3 secondary outcomes
Differences between groups for gingival index
Time frame: baseline, 3 month, 6 month
Differences between groups for detection of periodontal pathogens
Time frame: baseline, 3 month, 6 month
Differences between groups for levels of periodontal pathogens changes
Time frame: baseline, 3 month, 6 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2016.
- Individual participant dataSharing planned: No
Related trials for Gingivitis
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A Study to Assess the Efficacy of Two Brushing Regimens in the Reduction of Established Dental Plaque and Gingivitis
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Effectiveness of Personalized Digital Oral Health Intervention in Patients With Fixed Orthodontic Appliances.
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Not yet recruitingPhase 2
Efficacy of Thymus Vulgaris Mouthwash in the Management of Biofilm-Induced Gingivitis
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jorge Gamonal Aravena, Proffesor principal investigator
Faculty of Dentistry of University of Chile
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Treatment Gingivitis with Probiotic and Treatment Gingivitis conventional in people with Gingivitis, run by Jorge Gamonal at 1 site in Chile.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Joel E Bravo Bown, Proffesor (+5694540294, jbravo@odontologia.uchile.cl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Differences between groups for bleeding on probing changes (time frame: baseline, 3 month, 6 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2016.